(119 days)
The microMESAM® Basic-Set is used for recording the patient's respiratory nasal pressure during sleep. The device is intended for use as a screening device to determine the need for clinical diagnosis and evaluation by polysomnography based on the patient's test score.
The MicroMESAM® Basic-Set consists of a reusable microMESAM® recorder, disposable nasal pressure cannula and patient's instruction manuals, microMESAM® installation CD, system instruction manual for specialist medical personnel, batteries, reusable belt for attaching the microMESAM® recorder, USB cable, carrying bag, and Luer-lock caps. The microMESAM® recorder is a single channel battery-powered respiratory pressure sensor system and provides recordings of respiratory pressure during sleep. The physician prescribed device will help to recognise sleep-related respiratory disorders and lead to comprehensive clinical diagnosis and therapy. The patient may actually perform the recording at home by himself. The microMESAM® recorder must be fastened with the reusable belt on the patient's chest. All relevant respiratory information during sleep will be collected via nasal pressure cannula. The disposable plastic nasal pressure cannula is connected to the microMESAM® recorder and fixed at the patient's nose. After recording, the microMESAM® recorder must be returned to the physician. With the microMESAM® software installed on a personnel computer the physician has the possibility to generate a report with the recorded and analysed data.
Here's a breakdown of the acceptance criteria and study information for the microMESAM® Basic-Set, based on the provided text:
Acceptance Criteria and Study Information for microMESAM® Basic-Set
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a table format with numerical targets. However, the performance data section implies the criteria for substantial equivalence were met by demonstrating high correlation with the gold standard (PSG) and effective detection of Sleep Disordered Breathing (SDB). I've interpreted the key correlating factors and the derived sensitivities/specificities as the performance outcomes that demonstrate meeting implicit acceptance criteria for a screening device.
| Performance Metric (Implicit Acceptance Criteria) | Reported Device Performance |
|---|---|
| Signal Quality (Flow-time curves correlation with pneumotachograph) | Corresponded in 95% of respiratory events, with less than 4±2% difference in area under the curves. |
| Correlation of Apneas (with PSG) | r = 0.99 |
| Correlation of Hypopneas (with PSG) | r = 0.81 |
| Correlation of AHI (with PSG) | r = 0.98 |
| Mean difference in AHI (microMESAM vs PSG) | 3.8 |
| 1.96 Intervall of AHI difference (microMESAM vs PSG) | +11.1 to -3.5/h |
| Sensitivity for SDB (at AHI of 5) | 97.3% |
| Specificity for SDB (at AHI of 5) | 46% |
| Sensitivity for SDB (at AHI of 10) | 100% |
| Specificity for SDB (at AHI of 10) | 87.5% |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 50 patients
- Data Provenance: The document does not explicitly state the country of origin, but the submitting company is based in Germany. It is a prospective study, as it involved "50 patients suspected of having obstructive sleep apnoea" where microMESAM-generated automated analysis was compared with simultaneously collected PSG data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The study compared "MicroMESAM-generated automated analysis with manually scored results of simultaneously collected PSG data." This indicates that human experts were involved in scoring the PSG data, which served as the ground truth.
- Number of Experts: Not specified.
- Qualifications of Experts: The document does not explicitly state the qualifications of the experts who manually scored the PSG data. However, the phrasing "manually scored results of simultaneously collected PSG data" implies qualified sleep specialists or technicians trained in PSG scoring, as PSG is the "gold standard in the diagnosis of sleep disordered breathing (SDB)."
4. Adjudication Method for the Test Set
The document does not explicitly state an adjudication method (such as 2+1 or 3+1). It states that the microMESAM's automated analysis was compared to "manually scored results" of PSG. This suggests a direct comparison to a single expert's or a consensus's manual scoring of the PSG, but the specific process isn't detailed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not explicitly described. The study compared the device's automated analysis to manually scored PSG data, not to human readers with vs. without AI assistance.
- Effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as no MRMC study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the performance study describes the standalone performance of the microMESAM® Basic-Set's automated analysis. It explicitly states comparing "MicroMESAM-generated automated analysis" with the ground truth (manually scored PSG data). The device automates the analysis of apnoeas, hypopnoeas, flow limitations, and snoring.
7. The Type of Ground Truth Used
The primary ground truth used was expert consensus / manual scoring of Polysomnography (PSG) data. PSG is referred to as the "gold standard in the diagnosis of sleep disordered breathing (SDB)." Additionally, there was an initial comparison of signal quality where "pneumotachograph-generated curves" served as a ground truth for microMESAM's flow-time curves.
8. The Sample Size for the Training Set
The document does not specify a separate training set or its sample size. The study described focuses on the validation of the device, implying that the algorithm and its analysis capabilities were already developed.
9. How the Ground Truth for the Training Set Was Established
Since a training set is not explicitly mentioned, the method for establishing its ground truth is also not described in this document.
§ 868.2375 Breathing frequency monitor.
(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).